Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

Saint Vincent's Hospital, Korea

Status: Unknown

Conditions: Periampullary Tumors

Treatments: Drug: Octreotide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02920567

XC12MIMI0138V

Details and patient eligibility

About

This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide was injected subcutaneously every 8 hours for 7 days. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure and amounted.

Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.

Full description

This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide of 100ug(1mL) was injected subcutaneously just before operation and every 8 hours for 7 days postoperatively. The placebo group was managed with normal saline (1mL) for same period. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure (Barovac) and amounted.

Postoperative care of patients was same between groups such as pain control and supportive care. The amount of drained pancreatic juice via external stent was recorded everyday.

Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.

Enrollment: 282 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who will undergo pancreatoduodenectomy for periampullary tumors

Exclusion criteria

• Patients with preoperative pancreatitis
• Patients who did not undergo pancreatoduodenectomy
• Patients who underwent bypass surgery or total pancreatectomy
• Patients who injection of octreotide less than 5 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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282 participants in 2 patient groups, including a placebo group

octreotide

Experimental group

Description:

After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days

Treatment:

Drug: Octreotide

Placebo

Placebo Comparator group

Description:

After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days

Treatment:

Drug: Placebo